How Medtech Founders Should Sequence a Reimbursement Strategy Years Before VAC Approval Lands

June 18, 2026

Table of contents

How Medtech Founders Should Sequence a Reimbursement Strategy Years Before VAC Approval Lands

Key Takeaways

Medtech reimbursement strategy is a pre-clearance discipline, not a post-launch problem, Stanford research puts time to meaningful reimbursement at 5.7 years on average
Submitting to a Value Analysis Committee before securing stakeholder support is the most common rookie mistake; VAC veterans say never request approval until you know you have the votes
Surgeon retention is the financial argument VAC committees respond to most directly; clinical benefits translated into surgeon-retention dollars produce the strongest VAC outcomes
CPT code structure (Category I vs Category III) determines whether reimbursement is secure or just a tracking placeholder with no payer obligation
Pull-through from VAC approval to actual purchase orders requires its own playbook; many founders win VAC approval and still get zero revenue without the pull-through motion

You're 18 months from FDA clearance. The pivotal trial is enrolling. The board has the commercial timeline pointed at first revenue six months after clearance.

The reimbursement strategy slide in the deck has a single bullet: "secure CPT code at launch." There's no named market access lead, no payer-advisor relationships, no CPT code path documented.

But the gap between clearance and meaningful reimbursement is on average 5.7 years, not six months. So the company's 24-month runway post-launch doesn't fund the time it takes to land coverage.

And the founder finds out about the gap when the first Value Analysis Committee submission comes back with "we need to see established reimbursement before we approve."

This post lays out what medtech reimbursement strategy work looks like when sequenced properly, which decisions have to happen pre-clearance, and why the post-VAC pull-through phase often becomes the actual gate that blocks revenue.

Why the VAC Shift Forces Reimbursement Strategy to Start Earlier

The first thing most founders don't realise about medtech reimbursement strategy is how dramatically the buying-committee structure has shifted in the last decade. Decision-making has moved from individual clinicians to Value Analysis Committees, and the time and rigour required to navigate VAC has compressed the reimbursement window.

I covered this on an episode about how a billion-dollar M&A machine drives medtech growth:

"The shift we've shifted away from that to a lot more influenced by value analysis committees. You have to have a larger more sophisticated approach of like how are we going to get this through the VAC committee. The value analysis committee cannot be the place you start thinking about reimbursement strategy."

So the operating implication is clear. The medtech reimbursement strategy work has to happen before the company walks into the first VAC meeting.

That means before the first sales rep is hired, before the first commercial deck is built, and ideally before the pivotal trial protocol locks. The VAC committee won't wait for the company to catch up.

Why You Should Never Submit to VAC Without Knowing the Votes First

The single most expensive rookie mistake in medtech reimbursement strategy is submitting to a Value Analysis Committee before doing the stakeholder mapping work. Once a VAC submission gets a "no," the path to revisit the same decision opens up 9 to 18 months later, not next quarter.

I interviewed Mark Copeland on an episode about secrets to selling to the hospital Value Analysis Committee. Mark has navigated VAC submissions across dozens of accounts and named the rule directly:

"When you're getting your antibiotic on the p&t committee which was the pharmacy and Therapeutics is basically the V committee for pharmaceuticals do not request that it be approved until you already know it's going to be approved. I don't go to the committee until I know the votes."

So the discipline is to map every voting stakeholder on the committee, identify the surgeon champion, the procurement lead, the nursing representative, the finance lead, the medical director.

Then move each stakeholder one column to the right on the support spectrum (against → neutral → supportive → champion) over the months before submission. Only when the count of supportive and champion stakeholders crosses the threshold for approval does the formal submission happen.

That mapping work can't happen in the week before submission. It happens over months, with input from the design partners, KOLs, and clinical-trial sites that already have relationships inside the target hospital.

The companies that win VAC approvals consistently are the companies that did this cartography pre-clearance and started moving stakeholders before clearance even landed.

Surgeon Retention Is the Financial Argument VAC Responds To

Even with the stakeholder map in place, VAC submissions still need to translate the clinical case into financial terms VAC will weigh. The most reliable financial frame is surgeon retention.

Mark walked through this on the same episode:

"It's going to help you retain surgeons which is a major value analysis point of emphasis. You have to speak their language. It's going to make you $3.3–$3.7 million in annual hospital revenue. We finally got VAC approval and now we're still not getting any business."

So the surgeon-retention argument matters because it translates directly into hospital revenue. A surgeon who can't perform the procedures they want to perform leaves for another institution, taking case volume with them.

VAC committees respond to that argument because it shows up in their P&L impact metrics, not just in the clinical-benefit deck.

But the second half of Mark's quote is the warning that often gets missed. "We finally got VAC approval and now we're still not getting any business." Winning VAC approval is necessary.

It's not sufficient. The pull-through motion from approval to purchase orders is its own playbook, and many companies skip it because they treat VAC approval as the finish line.

How Category I and Category III CPT Codes Decide Reimbursement Security

The next critical piece of medtech reimbursement strategy is the CPT code structure. The category of code your procedure ends up under determines whether reimbursement is secure or just tracked.

I interviewed Cody Simmons, CEO of DermaSensor, on an episode about scaling clinical adoption using B2C strategies. Cody walked through the Category I versus Category III dynamic:

"You start with what's called a category 3 code which is often considered investigational code. The issue is why would doctors bother billing this code if it's not yet reimbursed by Medicare Medicaid and Commercial payers? Stanford published that paper recently right 5.4 years on average to get meaningful reimbursement"

So Category III is the investigational code. It exists. Payers can track utilization against it. But there's no payment obligation, which means clinicians have no financial reason to bill against it.

Moving from Category III to Category I requires up to five years of utilization data, peer-reviewed publications, and AMA panel review.

The medtech reimbursement strategy decision is whether the company can afford the 3-to-5-year Category III period before Category I coverage lands.

If the post-launch runway is 24 months, the gap is fatal unless the strategy includes private-payer coverage pathways, self-pay protocols, or cash-pay channels that don't depend on Category I status.

What Established CPT Codes Driving Payer Coverage Look Like in Practice

The clearest picture of what a successful medtech reimbursement strategy produces comes from the companies that have landed on the other side. The endpoint is established CPT codes with Medicare coverage, private payer follow-through, and built ROI models tied to clinical data.

I interviewed Robert from NeuroSignal on an episode about how the company is fixing stroke diagnosis with AI and robotics. Robert described the reimbursement endpoint:

"We have existing CPT codes. Because Medicare has picked that up, a vast majority of private payers have. So we have coding, coverage and payment that is very well established. We've built nice ROI models that complement our existing clinical data set."

That paragraph is what the right medtech reimbursement strategy outcome looks like operationally: coding (Category I CPT codes), coverage (Medicare and private payers), payment (established reimbursement rates), and ROI models that translate clinical data into financial impact stakeholders can underwrite.

Each of those four elements takes years to put in place. The companies that get there started the reimbursement strategy work pre-clearance.

The Post-VAC Pull-Through Phase

The phase most medtech reimbursement strategies underinvest in is post-VAC pull-through. Mark's earlier quote captures the failure mode: "we finally got VAC approval and now we're still not getting any business."

VAC approval changes what's possible at the hospital. It doesn't change what's purchased. The pull-through motion requires reigniting the surgeon champion to use the product, working with nursing and procurement to integrate the product into ordering systems, and tracking utilization weekly until the volume reaches a baseline the hospital considers normal.

So the medtech reimbursement strategy plan should include a post-VAC pull-through playbook with weekly check-ins, named utilization targets, and escalation paths when adoption stalls.

Founders who treat VAC approval as the end of the work end up with VAC-approved products generating zero purchase orders, which is materially worse than not pursuing the VAC at all because it consumes 9 to 12 months of sales-team capacity for no revenue.

For more on the broader market access work that runs alongside medtech reimbursement strategy, see the medical device market access playbook. And for the upstream commercialization sequencing, see the medtech commercialisation strategy framework.

What This Means for Medtech Founders

In my experience working with medtech founders, the medtech reimbursement strategy conversation typically starts after the first VAC rejection or after the first 90 days of post-launch revenue come in at 20% of plan. By that point, the company is in recovery mode, not strategy mode.

So the better practice is to put a medtech reimbursement strategy lead on the team before pivotal trial protocol locks.

The lead's job is to map the CPT code path, design the HEOR data capture into the pivotal trial, build the payer-advisor relationships that will inform Category III to Category I progression, and develop the VAC stakeholder cartography for the first 50 priority accounts.

None of those four deliverables can be built fast post-clearance. All four are cheap to build pre-clearance.

Frequently Asked Questions

What is a medtech reimbursement strategy?

A medtech reimbursement strategy is the integrated plan that defines how a medical device will achieve CPT code coverage, payer reimbursement, hospital Value Analysis Committee approval, and ongoing utilization.

The work spans CPT code path selection, Health Economics and Outcomes Research data design, payer-advisor engagement, VAC stakeholder mapping, surgeon-retention financial modelling, and post-approval pull-through execution. The strongest medtech reimbursement strategies start two years before FDA clearance.

How long does it take to land medtech reimbursement after FDA clearance?

Stanford research puts the average time from FDA clearance to meaningful reimbursement at 5.7 years for medical devices. The number varies by therapeutic area, CPT code path, and payer mix.

Companies that started medtech reimbursement strategy work pre-clearance compress this window meaningfully. Companies that defer the work until post-clearance hit the 5.7 year average or longer.

Why is Value Analysis Committee approval not enough on its own?

VAC approval changes what's possible at the hospital. It doesn't drive purchase orders by itself. The pull-through motion from VAC approval to actual revenue requires reigniting the surgeon champion, integrating the product into nursing and procurement ordering systems, and tracking utilization weekly until volume normalises.

Many medtech companies win VAC approvals and still produce zero revenue because the post-approval pull-through phase doesn't have its own playbook.

When should a medtech founder hire a market access lead?

The market access lead should be on the team before the pivotal trial protocol locks. The trial protocol determines whether secondary endpoints needed for HEOR materials can be captured as part of the existing trial work or whether they require expensive standalone studies later.

The CPT code path also has to be selected before the trial design closes, because the code path shapes what data will be required for payer coverage decisions. Founders who hire the market access lead post-clearance pay for both deliverables to be retrofitted at significant additional cost.

Listen to the Full Conversations

The episodes referenced in this post are available on The State of MedTech. Subscribe wherever you listen to podcasts.

About the Author

Omar Khateeb is the founder of MarketCraft and host of The State of MedTech, the number one podcast in the medtech industry.

He works with medtech founders and commercial leaders on market engineering, commercialisation strategy, and revenue growth. Visit marketcraft.ai or subscribe to The State of MedTech for weekly conversations with the people building the future of medical devices.